Effect of Weight Loss and CPAP on OSA and Metabolic Profile Stratified by Craniofacial Phenotype

NCT03287973 | Completed DMC

• 1 other identifier: OSA-Craniofacial study
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a common form of sleep-disordered breathing (SDB). Weight reduction has always been advocated in patients with OSA who are overweight and may lead to improvement in the severity of OSA. Previous study reported a randomized controlled trial of dietician-led lifestyle modification program (LMP) in 104 patients and found that LMP group had significantly more weight loss and reduced OSA severity, and the response was sustained after 8 months. This study is aimed to compare the effect of weight loss or CPAP alone on subclinical inflammation, insulin resistance and blood pressure in patients with obesity and moderate-to-severe obstructive sleep apnea, stratified according to the degree of craniofacial restriction. The study plans to recruit consecutive patients who have been referred to the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing with specific study entry criteria including an age of 18 or more, body mass index (BMI) \>25 kg/m2, and moderate to severe OSA diagnosed by home sleep study. Patients having conditions that will affect the serum level of hsCRP will be excluded.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• changes in hsCRP

  6 months

Secondary Outcomes (4)

• change in Epworth Sleepiness Scale (ESS)

  6 months

• Change of insulin sensitivity by Matsuda index

  6 months

• Change of facial measurements on photography

  6 months

• Change of anatomic measurements of upper airway on computed tomography imaging

  6 months

Study Arms (2)

Lifestyle modification program group

ACTIVE COMPARATOR

Patients with apnea-hypopnea index (AHI) ≥ 15/hr on home sleep study will participate in a dietitian-led lifestyle modification program (LMP) for 6 months. Patients will attend dietary consultation weekly in the first 4 months, and then monthly in the following two months.

Behavioral: Lifestyle modification

CPAP group

OTHER

Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.

Device: Continuous positive airway pressure (CPAP)

Interventions

Lifestyle modification BEHAVIORAL

A caloric reduction of 10-20% in daily energy intake from the patient's usual diet (i.e. a deficit ≥ 200 calories per day) will be set as the general initial goal, which will be adjusted subsequently based on changes in body weight with target body mass index (BMI) towards 23 kg/m2.

Lifestyle modification program group

Continuous positive airway pressure (CPAP) DEVICE

Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.

CPAP group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with moderate or severe obstructive sleep apnea ( apnea hypopnea index (AHI) ≥ 15); body mass index ≥25 kg/m2; age 18-70 years.

You may not qualify if:

• Predominant central sleep apnea; conditions that will affect the level of hsCRP; unstable cardiovascular disease (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure; neuromuscular disease affecting or potentially affecting respiratory muscles; moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake SaO2 \<92%); psychiatric disease that limits the ability to give informed consent or complete the study.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Ng SSS, Tam WWS, Lee RWW, Chan TO, Yiu K, Yuen BTY, Wong KT, Woo J, Ma RCW, Chan KKP, Ko FWS, Cistulli PA, Hui DS. Effect of Weight Loss and Continuous Positive Airway Pressure on Obstructive Sleep Apnea and Metabolic Profile Stratified by Craniofacial Phenotype: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Mar 15;205(6):711-720. doi: 10.1164/rccm.202106-1401OC.

  PMID: 34936531 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Susanna SS Ng, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Susanna Ng, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant who scores the sleep study and the laboratory technician who does the blood test are blinded to the intervention arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary assistant professor

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: September 15, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)